Mifamurtide is a synthetic immunomodulatory agent and a derivative of muramyl dipeptide (MDP). It is associated with activation of macrophages and monocytes and is used in pharmaceutical development for osteosarcoma, particularly as part of multimodal treatment strategies.
Mifamurtide is a lipophilic derivative known as muramyl tripeptide phosphatidylethanolamine (MTP-PE). The pharmaceutical substance is commonly represented as mifamurtide sodium hydrate and is designed for delivery in a liposomal formulation.
Mifamurtide is a specialized oncology and immunomodulatory pharmaceutical API used in the development of formulations involving macrophage and monocyte activation.
Important quality attributes for Mifamurtide may include identity, assay, related substances, water content, residual solvents, elemental impurities, lipid-related impurities and other product-specific analytical parameters.
CAS Number: 838853-48-8 (mifamurtide sodium hydrate)
Molecular Formula: C59H110N6NaO20P (mifamurtide sodium hydrate)
Molecular Weight: 1277.5 g/mol
Parent/free-acid form: MTP-PE
Parent Molecular Formula: C59H109N6O19P
Parent Molecular Weight: 1237.5 g/mol
Drug Class: Immunomodulatory Agent
Therapeutic Area: Oncology
Molecule Type: Synthetic Lipid-Modified Peptide Derivative
Mifamurtide activates components of the innate immune system, particularly monocytes and macrophages.
Its pharmacological activity includes:
Mifamurtide is taken up by monocytes and macrophages, where its active MTP-PE component stimulates intracellular immune signaling. This activation contributes to macrophage-mediated antitumor activity.
Mifamurtide API is relevant to:
Mifamurtide has been associated with treatment of high-grade, resectable, non-metastatic osteosarcoma in pediatric, adolescent and young adult patients in combination with postoperative multi-agent chemotherapy.
Mifamurtide is particularly relevant to osteosarcoma research and treatment development. Rather than directly acting as a conventional cytotoxic chemotherapy agent, it stimulates macrophage and monocyte activity and may enhance immune-mediated tumor cell killing.
Its immunomodulatory mechanism makes it relevant to research involving cancer immunology, innate immunity and macrophage-mediated antitumor responses.
Mifamurtide sodium hydrate has a complex chemical structure containing a muramyl peptide component, phospholipid portion and sodium counterion. PubChem lists the sodium hydrate form with a molecular weight of approximately 1277.5 g/mol.
The physical appearance, water content, particle characteristics and other solid-state properties should be controlled according to the applicable API specification.
A controlled Mifamurtide manufacturing process may involve:
Because Mifamurtide is a structurally complex lipid-modified peptide derivative, manufacturing and characterization require specialized analytical and process controls.
Typical Mifamurtide API testing may include:
Final numerical acceptance criteria should be taken from the approved product/API specification or current CoA rather than using generic limits.
Store Mifamurtide API in a tightly closed container under controlled pharmaceutical storage conditions, protected from excessive heat, moisture and direct light. The final storage temperature and handling conditions should follow validated stability data and the applicable manufacturer's specification.
Mifamurtide is relevant to research involving:
Mifamurtide is a lipid-modified immunomodulatory compound associated with activation of monocytes and macrophages. The commonly represented pharmaceutical sodium hydrate form has CAS Number 838853-48-8, molecular formula C59H110N6NaO20P, and molecular weight approximately 1277.5 g/mol.
| Parameter | Specification |
|---|---|
| Appearance | White crystalline powder or crystals |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.2% |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 1.0% |
| Water Content | NMT 1.0% |